Pre-Market Programs:

- New Product Development: Design Control & Validations

- Regulatory Filing: 510K in USA and International: CE, CFDA, PMDA, MFDS, ANVIZA, CMDCAS and others

Post-Market Programs:

- Compliance (Remediations on 483s, Warning Letter & Consent Decree)

- QMS and Processes Integration(CAPA, Complaints, GMP, Change Control & Supplier Mgmt.)

- Information Systems Enhancement (SAP, Agile, Oracle)

Corporate Training & Solutions Package:

- Lean Six Sigma (Basic or fundamental way to run the business efficiently) 

- Business Excellence (Overall company business strategy, processes and executions)

- DMAIC (Operational Excellence) for Existing Product, Process and Service

- DFSS (Design for Six Sigma) for New Product, New Process and New Service

- Kaizen (Quick Blitz Continuous Improvement)